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INDICATION

FOCALIN XR is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older and should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

FOCALIN XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN XR in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN XR may harm others, and is against the law.

Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs, or there is a family history of these problems.

FOCALIN XR should not be used if you or your child are very anxious, tense, or agitated; have an eye problem called glaucoma; have tics or Tourette's syndrome, or a family history of Tourette's syndrome; if you are taking, or have taken an antidepressant called a monoamine oxidase inhibitor (MAOI) in the past 14 days; or are allergic to anything in FOCALIN XR.

FOCALIN XR may not be right for you or your child.

What is the most important information I should know about FOCALIN XR?

The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines: sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, and increased blood pressure and heart rate. Tell your doctor if you or your child have any heart problems, heart defects, or high blood pressure, or a family history of these problems.

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, depression, new or worse aggressive behavior or hostility, and, in children and teenagers, new psychotic symptoms (such as hearing voices, believing things that are not true, or are suspicious) or new manic symptoms.

Circulation problems in the fingers and toes have been reported with stimulant medicines. Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your doctor right away if you or your child have any worsening signs of heart problems, such as chest pain, shortness of breath, fainting, worsening mental symptoms, or any signs of unexplained wounds appearing on fingers or toes.

Serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes and hives, and fever) have been reported in patients taking Focalin XR. Contact your doctor immediately if you have any of these symptoms when taking Focalin XR. Other serious side effects include seizures (mainly in patients with a history of seizures) and eyesight changes or blurred vision.

Painful and prolonged erections (priapism) have occurred with methylphenidate. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Talk to your doctor if your child experiences slowing of growth (height and weight). Children should have their height and weight checked often while taking FOCALIN XR. Your doctor may stop FOCALIN XR treatment if a problem is found during these checkups.

Tell your doctor about any other medications you or your child have recently taken or are currently taking. Do not start any new medicine while taking FOCALIN XR without telling your doctor first.

FOCALIN XR should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established. If you take FOCALIN XR for an extended period of time, your doctor may periodically take a blood test.

FOCALIN XR can be taken with or without food and should not be chewed, crushed, or divided. If you (or your child) cannot swallow the capsule whole, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing. From time to time, your doctor may stop FOCALIN XR treatment for a while to check ADHD symptoms.

Click here for full Prescribing Information, including Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.